FDA’s Gottlieb Rolls Out A Raft Of Biosimilar Reforms
Executive Summary
As the FDA publishes several key guidance documents on biosimilars and biologics, Commissioner Scott Gottlieb has outlined the latest steps in the agency’s ongoing efforts to support the market. These include measures to address the abuse of REMS, as well as transitioning products such as insulin and human growth hormone into the biologics framework.
You may also be interested in...
US Bill Urges Automatic Insulin Interchangeability
A draft Biosimilar Insulin Access Act, intended to waive US interchangeability requirements for FDA-approved biosimilar insulins, has been introduced by representative Glenn Grothman.
Should US Insulins Be Treated As Biologics?
Against a backdrop of continued outcry over insulin costs in the US and the looming FDA-imposed transition of insulins to biologic status in early 2020, legislators and manufacturers alike are still lobbying for alternative approaches to the essential diabetes treatment.
Novo Nordisk Follows Lilly To Lower-Priced Insulin
Novo Nordisk will launch US authorized generics of its NovoLog and NovoLog Mix at half the price of the brands from the start of 2020.